270 Participants Needed

ALN-ANG3 + Evinacumab for Diabetic Kidney Disease

(ANCHOR-POC Trial)

Recruiting at 9 trial locations
CT
Overseen ByClinical Trials Administrator
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Regeneron Pharmaceuticals
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two experimental drugs, ALN-ANG3 and evinacumab, to determine their safety and effectiveness for people with diabetic kidney disease. Researchers aim to learn about any side effects and how the drugs move through the body. Participants with type 2 diabetes and kidney problems affecting daily life might be suitable candidates. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that ALN-ANG3 and evinacumab have been generally safe in earlier studies. ALN-ANG3 is still under investigation to further assess its safety and effectiveness. Participants in past studies have not reported major safety issues, but detailed safety information continues to be gathered.

For evinacumab, studies have found it to be generally well-tolerated. Previous research used it to treat high cholesterol, and patients did not experience significant side effects. Notably, the FDA has approved evinacumab for other conditions, indicating a certain level of safety.

Overall, while both treatments are still under study for use in diabetic kidney disease, existing research suggests they are generally well-tolerated by patients. However, more information is needed to fully understand any possible side effects.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about ALN-ANG3 and evinacumab for diabetic kidney disease because these treatments target underlying issues differently than current options like ACE inhibitors or ARBs, which mainly control blood pressure. ALN-ANG3 works by inhibiting a protein involved in lipid metabolism, potentially addressing the disease's root causes by reducing harmful lipid levels. Evinacumab is an antibody that lowers bad cholesterol by targeting a protein called angiopoietin-like 3, which could provide additional benefits for kidney function. These novel approaches could offer new hope for patients by not just managing symptoms but also slowing the disease's progression.

What evidence suggests that this trial's treatments could be effective for diabetic kidney disease?

Research has shown that ALN-ANG3, which targets the protein ANGPTL3, may help manage kidney diseases related to fat issues. Studies have found that blocking ANGPTL3 can benefit conditions like diabetic kidney disease. In this trial, some participants will receive ALN-ANG3 combined with Evinacumab, another promising treatment. Past studies demonstrated that Evinacumab lowers bad cholesterol (LDL) by 45.5%. Lowering cholesterol is important because it can help prevent kidney damage. Together, these drugs offer hope for treating diabetic kidney disease by addressing underlying fat problems.13456

Who Is on the Research Team?

CT

Clinical Trial Management

Principal Investigator

Regeneron Pharmaceuticals

Are You a Good Fit for This Trial?

Adults with type 2 diabetes and diabetic kidney disease can join this trial. They must be managing their diabetes through medication or lifestyle changes, have an HbA1c level between 6.5 to 10%, eGFR of 30 to 90 mL/min/1.73 m^2, and a specific range of albumin in their urine (UACR of 500 to 5000 mg/g).

Inclusion Criteria

My HbA1c level is between 6.5% and 10%.
My urine test shows moderate to severe albumin levels.
Key
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either ALN-ANG3, evinacumab, or placebo to assess safety and efficacy

12 weeks

Pharmacokinetics

Blood samples are taken to measure the concentration of the study drugs at different times

Concurrent with treatment phase

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • ALN-ANG3
  • Evinacumab

Trial Overview

The trial is testing the safety and effectiveness of two experimental drugs: ALN-ANG3 and evinacumab for treating diabetic kidney disease. Participants will receive either one of these drugs or a placebo while researchers monitor drug levels in the blood and observe outcomes.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Placebo Group

Group I: ALN-ANG3 + evinacumab placeboExperimental Treatment2 Interventions
Group II: ALN-ANG3 + evinacumabExperimental Treatment2 Interventions
Group III: ALN-ANG3 placebo + evinacumab placeboPlacebo Group2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Regeneron Pharmaceuticals

Lead Sponsor

Trials
690
Recruited
948,000+
Founded
1988
Headquarters
Tarrytown, USA
Known For
Precision medicine
Top Products
Dupixent, EYLEA, Libtayo, Praluent
Leonard Schleifer profile image

Leonard Schleifer

Regeneron Pharmaceuticals

Chief Executive Officer since 1988

MD and PhD in Medicine

George Yancopoulos profile image

George Yancopoulos

Regeneron Pharmaceuticals

Chief Medical Officer since 1997

MD from Harvard Medical School

Citations

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Study to Assess the Effects of Angiopoietin-like Protein 3 (ANGPTL3) Inhibition in Adult Participants With Diabetic Kidney Disease (ANCHOR-POC).

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